Prevalence of Deficiency of Vitamin D in Critically Ill Patients

Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis

Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay .

Study Overview

• Status: Completed
• Conditions: Critical Illness; Vitamin D Deficiency

Detailed Description

Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality.

The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.

• Study Type: Observational
• Enrollment (Actual): 662

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a multi-center, cross-sectional study involving four medical center in Taipei, Taiwan, which are National Taiwan University Hospital (NTUH), Far Eastern Memorial Hospital (FEMH), MacKay Memorial Hospital (MMH), and Taipei Medical University Hospital (TMUH). The target population is all the ICU patients, divided into four groups according to the length of ICU stay. The serum level of vit D, ICU event such as infection, ventilator dependency is to be recorded.

Description

Inclusion Criteria:

• All ICU patients

Exclusion Criteria:

• 1, Less than 20 years 2, BMI < 18 kg/m^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Group 1; Patients admitted to ICU less than 48 hours and the anticipated stay is less than 5 days. Take blood sample on the day of enrollment.
Group 2; Patients admitted to ICU less than 48 hours and the anticipated stay is longer than 5 days. Take blood sample on the day of enrollment, 7th, 14th, 21st, and 28th. Stop blood sample once exit.
Group 3; Patients admitted to ICU 3~7 days. Take blood sample on the day of enrollment.
Group 4; Patients admitted to ICU 8~14 days. Take blood sample on the day of enrollment.
Group 5; Patients admitted to ICU 15~28 days. Take blood sample on the day of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of Vitamin D deficiency	Investigate the prevalence of vitamin D deficiency among groups	1 day at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of mortality on 28th and 90th day in group 2	Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 2	90 days
Difference of mortality on 28th and 90th day in group 3, 4, and 5	Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 3, 4, and 5	90 days
Serial changes of serum vitamin D levels in group 2	investigate the serum vitamin D levels at different time points in group 2	28 days
Difference of 28-day ventialtor-free days	Compare the 28-day ventialtor-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups	28 days
Difference of 28-day ICU-free days	Compare the 28-day ICU-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups	28 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chung-Wei Chen, MD, Far Eastern Memorial Hospital; Principal Investigator: Li-Kuo Kuo, MD, Mackay Memorial Hospital; Principal Investigator: Kuo-Ching Yuan, MD, Taipei Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2018
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Critical Illness; Vitamin D Deficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Critical Illness
• Other Study ID Numbers: 201805087RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No